G1 Therapeutics, Inc.

Today, and thank you for standing by, welcome to the G1 Therapeutics fourth quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Will Roberts, Corporate Communications. Please go ahead.

Thank you, Rivka. Good morning, everyone, and welcome to the G1 conference call to discuss our fourth quarter and full year 2023 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, g1periodics.com. On this morning's call, the team will provide a business overview of this 2023 fourth quarter and full year, including an update on our clinical programs and our commercial progress in that period with COSELLA, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum or topazide-containing regimen or topazecan-containing regimen for extensive-state small-cell lung cancer. As Rivka mentioned, a Q&A session will follow the prepared remarks. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risk and uncertainty that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risk and uncertainties, please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, February 28, 2024. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malek, our Chief Medical Officer, and John Umstead, our Chief Financial Officer. With that, I'll turn the call over to Jack.

Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. From a commercial perspective, as you'll hear from John and Andrew, we experienced strong Cosella growth in the fourth quarter of 2023, including revenue and volume growth of 29% and 19% respectively. Thanks to this progress, and that which we expect in 2024, we have provided full year 2024 net product sales guidance of between 60 and 70 million. That said, as we discuss the milestones we have achieved during the fourth quarter, it's essential we continue to look forward to and prepare for the opportunities ahead. Namely, that of category leadership in triple negative breast cancer if we are successful in our clinical programs. First, as you'll hear from Raj, the final results from our ongoing phase three, preserve two trial of trilocycline in the metastatic setting are expected in the third quarter of this year. Given our statistical boundaries, if our trial is successful in generating results similar to that of our phase two trial, they would be among the most important data generated in the first line metastatic setting in both PD-L1 positive and negative tumors to date. Beyond that, the use of antibody drug conjugates or ADCs is appropriately becoming commonplace in the second line and later TMDC treatment settings in addition to other tumor types. We have shown promising benefits thus far in our ongoing Phase II trial when trilocyclic is combined with a trope II ADC, including improvements in tolerability and, more recently, in initial overall survival. We expect updated results from that trial mid-year. With these and other recent results, we believe that continued clinical success in these trials could position G1 for category leadership across the spectrum of TMBC, in addition to our work in extensive stage small cell lung cancer. On today's call, Andrew will cover our recent commercial results. Raj will provide an update on our clinical pipeline, including our progress toward final results with our phase three Preserve2 trial. John will then discuss the financial results for the quarter, as well as our 2024 guidance. Finally, I'll be back with some concluding comments. With that, I'll turn the call over to Andrew.